Orexigen to Resubmit Weight-Loss Pill for FDA ApprovalMonday, November 25, 2013
San Diego-based Orexigen Therapeutics Inc. will soon reapply for regulatory approval of its weight-loss pill, Contrave, after reporting that interim results from a large-scale study showed the drug doesn’t significantly increase heart disease risk in patients.
Orexigen will submit a new drug application to the Food and Drug Administration in the next few weeks — it said in a regulatory filing — and it could possibly be approved by June 2014.
Shares for the company rose 14 percent in early trading Nov. 25, to $6.47. If approved, Contrave will be the third weight-loss drug to achieve Food and Drug Administration approval since 2012. Two other drugs — Belviq from from San Diego’s Arena Pharmaceuticals Inc. and Qsymia from San Francisco’s Vivus Inc. — are currently being marketed for weight loss, but have struggled in commercialization.
Orexigen initially filed with the FDA in 2010, but the application was rejected in 2011 — despite a positive endorsement from a panel of physicians and scientists — because the government agency said Orexigen needed to show more robust clinical data on how Contrave affected a patient’s cardiovascular health.
The study, which is still ongoing, is examining the drug’s effect on 8,900 patients and would continue even after potential approval from the FDA, Orexigen said in the filing. The company hasn’t reported the specifics of the study’s interim analysis, as Chief Executive Michael Narachi said during a Nov. 25 analyst call that it might skew the results of the ongoing trial.
“Unfortunately, you are going to have to take assurance from those of us who have seen the totality of information,” Narachi said.
— Meghana Keshavan